中国-欧盟药品质量相关法规研讨培训资料欧盟对伪劣药品的新立法

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1、TheNewEULegislationon‘FalsifiedMedicines’ImportationofActivePharmaceuticalIngredients(API)Directorate-General‚Healthandconsumers‘Beijing,12July2012HealthandConsumers欧盟对“伪劣药品”的新立法原料药的进口(API)卫生和消费品总司北京,2012年７月１２日HealthandConsumers165Outlineofthepresentation1)Introduction2)P

2、resentationofnewrulesonAPI(focusonimportation)3)NextstepsforimplementationHealthandConsumers提纲1)介绍2)原料药新条例的陈述/(主要集中于进口)3)下一步的执行HealthandConsumers166Introduction•TheCommunitycodeformedicinesforhumanusehasbeenamendedtoaddress‘falsifiedmedicines’,andissuesof'qualityofactives

3、ubstances'•Textwaspublishedinthe„OfficialJournal“on1July2011(Directive2011/62/EU)HealthandConsumers介绍•欧共体人用药品的法律已经得到修订,以解决“伪劣药品”和“原料药质量”这一问题•其文本内容已公布于2011年7月1号的官方杂志(2011/62/EU指令)HealthandConsumers167MaincontentsoftherulesA.B.C.D.ActorsinOnlineSafetythesupplyActivepharmafe

4、atureschainsubstanciescesHealthandConsumers条例主要内容A.B.C.D.供应链条上的在线药物安全性特征活跃者活性物质HealthandConsumers168Activesubstances•Registration•Transparency•Importation•Distribution•AuditbymanufacturersoffinishedproductsHealthandConsumers活性物质•注册•透明性•进口•批发•终产品制造商进行的审计HealthandConsumers1

5、69Importation–basicrule•Manufacturingofactivesubstanceshastocomplywith'GoodManufacturingPractices‘•WheretheactivesubstanceismanufacturedoutsidetheEU,themanufacturingstandardhastobe'equivalent'tothatintheEUHealthandConsumers进口–基本条例•活性物质的生产必须遵循欧盟GMP标准•当活性物质由欧盟以外的国家生产时,生产标准必

6、须等同于欧盟GMP标准HealthandConsumers170Importationwrittenconfirmation(1)•TheimportationofanactivesubstancehastobeaccompaniedbyawrittenconfirmationthattherulesformanufacturingandinspectionsareatleastequivalenttothoseintheEU•Writtenconfirmationisissuedbytheauthorityoftheexportingc

7、ountry•Issuedatcentral,regional,orlocallevel•Writtenconfirmation'persubstance,perplant'•Writtenconfirmationhastobeissuedforallplants–alsothosethathavebeeninspectedbytheEUHealthandConsumers进口书面确认(1)•活性物质的进口必须随带一份书面确认，以声明条例中规定的活性物质生产和检查标准至少与欧盟标准一致•书面确认由出口国的药政当局颁发•基于中央、地区或当地

8、政府级别水平颁发•书面确认‘每一种物质，每一个工厂'•书面确认必须针对所有工厂颁发-也针对那些已被欧盟检查过的工厂HealthandConsumers171Importationwritten